BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT REACTION VESSEL

    MDR report key: 1341565 · Received March 13, 2009

    Report

    Report Number
    1415939-2009-00186
    Event Type
    Malfunction
    Date Received
    March 13, 2009
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Removal / Correction Number
    1415939-2/27/09-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW, THE CUSTOMER ISSUE IS ASSOCIATED WITH REMEDIAL ACTION REPORTING NUMBER (B)(4), AS THE LOT OF THE SUSPECT REACTION VESSEL WAS IN USE AT THE CUSTOMER FACILITY. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE INVESTIGATION UNIT HAS EVALUATED THIS CUSTOMER COMPLAINT AND HAS DETERMINED THAT IT IS NOT ASSOCIATED WITH REMEDIAL ACTION REPORTING NUMBER 1415939-2/27/09-003-R AND IS THEREFORE UNASSIGNED. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION DETERMINED THE CAUSES OF THE INCREASE IN FREQUENCY OF STATIC DISCHARGE EVENTS WERE DUE TO THE ARCHITECT REACTION VESSELS (RVS) SUPPLIER'S MANUFACTURING MATERIAL AND MANUFACTURING PROCESSES. THE PREVIOUS INVESTIGATION IDENTIFIED RV LOTS MADE FROM A PARTICULAR POLYPROPYLENE RESIN LOT WERE RESPONSIBLE FOR A MAJORITY OF THE STATIC DISCHARGE EVENTS. ANALYSIS OF THIS RESIN LOT DETERMINED IT HAS UNIQUE COMPOSITIONAL AND ANALYTICAL CHARACTERISTICS WHEN COMPARED TO OTHER RESIN LOTS, WHICH FACILITATED THE BUILD-UP OF STATIC CHARGE ON THE RVS. THE PREVIOUS INVESTIGATION ALSO IDENTIFIED VARIABLES WITHIN THE SUPPLIERS' MOLDING MANUFACTURING PROCESS THAT CONTRIBUTED TO STATIC CHARGE VARIATION ACROSS RV LOTS. THE LATEST INVESTIGATION IDENTIFIED ADDITIONAL VARIABLES WITHIN THE SUPPLIERS MOLDING MANUFACTURING PROCESS. ABBOTT HAS IMPLEMENTED MORE STRINGENT STATIC CHARGE SAMPLING AND TESTING FOR ACCEPTANCE OF ALL INCOMING RV LOTS FROM OUR SUPPLIER. ABBOTT HAS WORKED IN CLOSE COLLABORATION WITH OUR SUPPLIERS TO ASSURE CONSISTENCY OF INCOMING RESIN MATERIAL, AND TO IMPROVE THE SUPPLIER'S MOLDING PROCESS TO REDUCE THE POTENTIAL GENERATION OF STATIC CHARGE.

    Description of Event or Problem · 1

    PHARMACY EMPLOYEE WAS PACKAGING A MAIL ORDER PRESCRIPTION WHICH INCLUDED INSULIN SYRINGES AND RECEIVED A NEEDLE STICK WHILE ATTEMPTING TO BUBBLE WRAP THE PRODUCT. IT WAS DETERMINED THAT TWO -2- OF THE TEN -10- SYRINGES DID NOT HAVE THE PROTECTIVE CAP ON THE NEEDLE. BD INSULIN SYRINGE WITH ULTRA FINE NEEDLE, 8 MM, 31 GAUGE, 1 ML NDC# 08290-8418-01 LOT # 01725145. DATES OF USE: (B)(6)2010.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 400 MG/DL AND 104 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED ERROR CODES 1007, UNABLE TO PROCESS TEST, ACTIVATED READ FAILURE AND 1006, UNABLE TO PROCESS TEST, BACKGROUND READ FAILURE OCCURRED ON THE ARCHITECT I2000SR ANALYZER. THE ISSUE WAS RESOLVED AFTER THE REACTION VESSEL LOT WAS CHANGED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT REACTION VESSEL REACTION VESSELS FOR CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAYS JJE ABBOTT LABORATORIES 65386P100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR